Learn how to view and report on eConsent form responses in Study Connect.
Note Veeva eConsent may be provided by your sponsor for use on a Connected Study or enabled for your SiteVault account as a paid add-on to use across all studies. Contact the Site Success Team to learn more.
Viewing eConsent Form Responses
You can view and report on the eConsent form questions, response options, and signatures collected from participants in MyVeeva for Patients during the eConsent process.
Complete the following steps to view a study participant’s eConsent form responses:
- In Study Connect, select eConsent on the left menu.
- On the Participants tab, select the participant beneath the Patient Name column. The participant’s page opens
- Expand the Form Responses section. The participant’s and any signatories’ signatures and responses and associated questions are displayed on a table with additional information such as the status of the response and the associated blank and signed ICFs.
After a participant and any additional signatories complete an eConsent form that contains a signature or questions and response options, SiteVault records the signatures and responses in the participant’s record. The responses are added in a Draft status and are updated to a Current status once the site user who sent the document countersigns the form. If you send an updated eConsent form with updated signature, questions, and response options, the previous responses are moved to a Superseded status and the newly collected responses are made Current.
Reporting on eConsent Form Responses
Research Organization Administrator or Site Administrator users can create a report to report on eConsent form responses. For example, you can create a report to view responses across one or more participants for one or more questions or signatures, or you can create a report to view Approved for Use form signatures, questions, and answers along with any associated Superseded responses.
The signature, question, and response names are defined by what is entered in the editor on the blank ICF. They can be either the default names or customized names. You can use the labels to aggregate response data across separate documents and studies when you create reports. We recommend that you use unique labels in a data set for easy organization and reporting. See Using the Veeva eConsent Editor in Clinical Operations Help for more information.